Report recommends national medical device evaluation network for better safety


As important as innovations in medical device technology are to improving patient outcomes, the effectiveness of these new tools is difficult to gauge. A new report recommends the formation of a national medical device evaluation system would be an effective way to evaluate the data produced by electronic medical devices and better discern their effects on patients.

Researchers from Durham, N.C.-based Duke University's Duke-Margolis Center for Health Policy wrote that such a network would be composed of voluntary partnerships across manufacturers, patient communities and government agencies, among others.

"As envisioned, NMDES is a flexible, virtual system that builds on and supports existing activities that are generating evidence on medical devices as well as evidence relevant to many other purposes, such as enhancing quality of care and care coordination," they wrote. "It would undertake specific activities to improve safety surveillance and enable more efficient FDA decision-making, and support the use of the same interoperability-focused connections and tools by other stakeholders for their evidence development needs, such as premarket approval and clearance as well as payer coverage and reimbursement."

According to the researchers, there is a critical public health need for such a network to organize, utilize, evaluate and secure medical device data. Hospitals and patients are increasingly using devices to gain a more nuanced understanding of individuals' health and to mine that information for valuable insights that could improve the health and prevent harm for many.

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